NCT02197585

Brief Summary

To compare fixation with glubran2 with suture during surgery por primary inguinal hernia. Hypothesis: Glue may induce less complications and chronic pain than suture

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable chronic-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

4 years

First QC Date

July 21, 2014

Last Update Submit

July 21, 2014

Conditions

Chronic Pain

Keywords

Male patientsAge > 18 yearPrimary herniaglue

Outcome Measures

Primary Outcomes (1)

  • Chronic pain after two years

    24 months

Study Arms (2)

Glue

EXPERIMENTAL

Mesh fixation with glue

Procedure: Inguinal mesh hernioplasty

Suture

ACTIVE COMPARATOR

Mesh fixation with suture

Procedure: Inguinal mesh hernioplasty

Interventions

Inguinal mesh hernioplastyPROCEDURE
GlueSuture

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients
  • Aged more than 18 years
  • Primary inguinal hernia

You may not qualify if:

  • Inguinoscrotal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • JA Pereira, MD

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medico Adjunto Cirugia General

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 22, 2014

Study Start

June 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 22, 2014

Record last verified: 2014-07